CHILD DEVELOPMENT IN RELATION TO EARLY OTITIS MEDIA

与早期中耳炎相关的儿童发育

• 批准号: 2888989
• 负责人: JACK L PARADISE
• 金额: $ 138.45万
• 依托单位: CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-06-01 至 2002-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2888989
• 关键词: audiometry; behavioral /social science research tag; child psychology; clinical research; clinical trials; cognition disorders; ear disorder diagnosis; hearing tests; human subject; human therapy evaluation; infant human (0-1 year); language development; otitis media; preschool child (1-5); social psychology; speech disorders; tympanoplasty

DESCRIPTION (Adapted from the Investigator's Abstract): This application is for continuing support of a study, initiated in June 1991, whose main objectives are to determine whether persistent otitis media with effusion (OME) during the first 3 years of life results in lasting impairments of speech, language, cognitive, or psychosocial development, and if so, whether prompt tympanostomy-tube placement (TTP) prevents or lessens the impairments. Secondary objectives are to determine whether increasing the duration of OME required before undertaking TTP results in fewer operations or in altered long-term otologic or audiologic outcomes, and to chart the occurrence and course of otitis media (OM) and associated hearing loss in young children, distorted as little as possible by surgical interventions. Previous studies of OM in relation to later developmental impairment have been inconclusive and contradictory, and unsuited, because of their associational design, to address the issue of causality. A total of 6400 well infants aged <2 mo from 2 hospitals and 6 private pediatric practices will have been enrolled over a 54-month period ending Dec 1995. Their middle-ear status is monitored monthly. Those who develop acute OM or persistent OME receive antimicrobials. In those with long > 8 wk duration audiometry is scheduled monthly. Up to age 3 yr, children who reach specified criteria regarding persistent OME are, subject to consent, randomized to receive TTP either promptly ("early-TTP") or after a defined extended period if OME remains present ("late-TTP"). Thus a high-OME population is divided into 2 groups who can be assumed to have equivalent developmental potential: an early-TTP group most of whom become relatively OM-free, and a late-TTP group most of whom continue to have OM for varying periods. If the late group subsequently has less favorable developmental outcomes, persisting OM will presumably have been causal. Development is assessed subjectively in all subjects at ages 1 and 2 yr via parent questionnaires. Formal tests of speech, language, cognition, and psychosocial development are administered at ages 3, 4, and 6 yr to all subjects who had met randomization criteria and to a sample of others representing a spectrum of OME experience. Analyses of test results in these groups will enable determinations of whether associations, either short- or long-term, exist between persistent early OME and later developmental impairments; if so, whether the associations are causal; and whether prompt TTP is effective in preventing or lessening such impairments. As of Oct 5, 1995, 6030 children had been enrolled, 376 had met randomization criteria, and 292 had been randomly assigned to early- or late-TTP groups. Analyses to date have provided new information about the epidemiology of OM, about the diagnostic predictive value of tympanometry, and about correlations between cumulative OME duration and language and behavior at ages 1 and 2 yr. If continued, this study will provide new knowledge that will make possible more rational, evidence-based management of OM in infants and young children, and thereby benefit children and substantially influence child health care practices and costs.

描述(改编自《调查员摘要》)：此应用程序是 继续支持1991年6月启动的一项研究，其主要内容 目的是确定持续性中耳炎是否伴有渗出性 (OME)在生命的前3年会导致永久性的损害 言语、语言、认知或心理社会发展，如果是，是否 及时鼓膜造口置管(TTP)可防止或减轻 减损。次要目标是确定是否增加 在进行TTP之前需要OME的持续时间会减少操作 或改变的长期耳科或听力学结果，并绘制 中耳炎(OM)及相关听力损失的发生和病程 年幼的儿童，通过手术干预尽可能少地扭曲。 之前关于OM与后来的发育障碍的研究已经 没有定论，相互矛盾，而且不合适，因为他们 关联设计，以解决因果关系问题。总计6400个 来自2家医院和6家私人儿科诊所的2个月大的婴儿 将在截至1995年12月的54个月期间内登记。他们的 中耳状态每月监测一次。患上急性OM或 持久的OME接受抗菌药治疗。在持续时间较长的&gt；8 wk中 听力测试计划按月进行。3岁以下的儿童，达到 关于永久性OME的具体标准是，如果获得同意， 随机接收TTP，或立即接收TTP(“早期TTP”)或在定义的 如果OME仍然存在，则延长期限(“延迟TTP”)。因此，高OME 人口分为两组，可以假设这两组人口具有等价性 发展潜力：TTP早期人群，他们中的大多数人变得相对 无OM，和TTP晚期组，他们中的大多数人继续患有OM以进行变化 句号。如果后一组随后有不太有利的发展 结果，持续的OM可能是有因果关系的。发展是 在1岁和2岁时通过父母对所有受试者进行主观评估 问卷调查。正式的语言、语言、认知和语言测试 心理社会发展在3岁、4岁和6岁时对所有人进行 符合随机标准的受试者和其他受试者的样本 代表了一系列OME体验。年检测结果分析 这些小组将能够确定是否存在关联， 在持续性早期OME和后期OME之间存在短期或长期 发育障碍；如果是，这种联系是否有因果关系；以及 迅速的TTP在预防或减轻此类损伤方面是否有效。 截至1995年10月5日，已有6030名儿童入学，376名儿童 随机标准，292人被随机分配到早期-或 晚期TTP组。到目前为止的分析提供了关于 OM的流行病学，关于鼓室导纳的诊断预测价值， 以及关于OME累计持续时间与语言和 1岁和2岁时的行为。如果继续下去，这项研究将提供新的 将使更合理的循证管理成为可能的知识 在婴幼儿中传播OM，从而造福于儿童和 在很大程度上影响儿童保健做法和成本。